Skin ConditionNCT05591352
Efficacy Testing of Chenopodium Formosanum Extracts on Skin Beauty
A study testing Chenopodium formosanum extracts sachet in people with Skin Condition, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess Chenopodium formosanum extracts on skin condition improvement Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Condition
- What is being tested?
- Chenopodium formosanum extracts sachet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged above 20 years old
Who cannot join
- Subject who is not willing to participate in this study.
- Patients with diseases of the skin, liver, kidney.
- Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
- Female who is pregnant or nursing or planning to become pregnant during the course of the study.
- Received facial laser therapy, chemical peeling or UV overexposure (> 3 hr/week) in the past 4 weeks.
- Constant drug use
- Students who are currently taking courses taught by the principal investigator of this trial.
Trial locations and contacts
1 site in 1 country.
About this study
To assess Chenopodium formosanum extracts on skin condition improvement
- Conditions
- Skin Condition
- Being tested
- Chenopodium formosanum extracts sachet, Placebo sachet
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chenopodium formosanum extracts sachetDietary supplement
Also called Formosa Ruby sachet
consume 1 sachet per day
Placebo sachetDietary supplement
consume 1 sachet per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo sachet | Placebo comparator | consume 1 sachet per day Receives: Dietary Supplement: Placebo sachet |
| Chenopodium formosanum extracts sachet | Experimental | consume 1 sachet per day Receives: Dietary Supplement: Chenopodium formosanum extracts sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
Measured: Change from Baseline skin wrinkles at 8 weeks
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Measured: Change from Baseline skin texture at 8 weeks
The change of skin collagen density
DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
Measured: Change from Baseline skin collagen density at 8 weeks
The change of skin elasticity
Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units
Measured: Change from Baseline skin elasticity at 8 weeks
Secondary outcomes (7)
The change of skin melanin index
Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units
Measured: Change from Baseline skin melanin index at 8 weeks
The change of skin L* value
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100
Measured: Change from Baseline L* value at 8 weeks
The change of skin erythema index
Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units
Measured: Change from Baseline skin erythema index at 8 weeks
The change of skin moisture
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Measured: Change from Baseline skin moisture at 8 weeks
The change of transepidermal water loss (TEWL)
Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²
Measured: Change from Baseline TEWL at 8 weeks
The change of skin pores
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
Measured: Change from Baseline skin pores at 8 weeks
The change of AGEs of blood
Fasting venous blood was sampled to measure concentrations of AGEs
Measured: Change from Baseline AGEs at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Nov 2022
- Primary completion13 Jan 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Hua Liang, Principal investigator, Chia Nan University of Pharmacy ＆ Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591352
- Sponsor's protocol ID
- 22-043-B
- Status last verified
- Nov 2023
- First submitted
- 19 Oct 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Testing of Chenopodium Formosanum Extracts on Skin Beauty
- ClinicalTrials.gov ID
- NCT05591352
- Acronym / sponsor ID
- 22-043-B
- Conditions
- Skin Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess Chenopodium formosanum extracts on skin condition improvement
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo sachet | Placebo comparator | Dietary Supplement: Placebo sachetconsume 1 sachet per day |
| Chenopodium formosanum extracts sachet | Experimental | Dietary Supplement: Chenopodium formosanum extracts sachetconsume 1 sachet per day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults aged above 20 years old
Key exclusion criteria (7 listed)
- Subject who is not willing to participate in this study.
- Patients with diseases of the skin, liver, kidney.
- Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
- Female who is pregnant or nursing or planning to become pregnant during the course of the study.
- Received facial laser therapy, chemical peeling or UV overexposure (> 3 hr/week) in the past 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chenopodium formosanum extracts sachetAlso: Formosa Ruby sachetconsume 1 sachet per day | Dietary supplement | Chenopodium formosanum extracts sachet |
| Placebo sachetconsume 1 sachet per day | Dietary supplement | Placebo sachet |
Primary outcome
The change of skin wrinkles
Time frame: Change from Baseline skin wrinkles at 8 weeks
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
The change of skin texture
Time frame: Change from Baseline skin texture at 8 weeks
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
The change of skin collagen density
Time frame: Change from Baseline skin collagen density at 8 weeks
DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
The change of skin elasticity
Time frame: Change from Baseline skin elasticity at 8 weeks
Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units
7 secondary outcomes
The change of skin melanin index
Time frame: Change from Baseline skin melanin index at 8 weeks
The change of skin L* value
Time frame: Change from Baseline L* value at 8 weeks
The change of skin erythema index
Time frame: Change from Baseline skin erythema index at 8 weeks
The change of skin moisture
Time frame: Change from Baseline skin moisture at 8 weeks
The change of transepidermal water loss (TEWL)
Time frame: Change from Baseline TEWL at 8 weeks
The change of skin pores
Time frame: Change from Baseline skin pores at 8 weeks
The change of AGEs of blood
Time frame: Change from Baseline AGEs at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Hua Liang principal investigator
Chia Nan University of Pharmacy ＆ Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chenopodium formosanum extracts sachet in people with Skin Condition, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of skin wrinkles (time frame: Change from Baseline skin wrinkles at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.